Validating Pharmaceutical Systems: Good Computer Practice In Life Science Manufacturing
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Validating Pharmaceutical Systems: Good Computer Practice In Life Science Manufacturing

by John Andrews (Author),
Informa Healthcare (Publisher)
Product Specifications
Book Description
This highly readable text offers a pragmatic approach to the validation of automated/computerized systems, an essential step for maintaining compliance with global regulatory authorities, such as the FDA. It examines the different levels of automated systems used throughout the drug development, manufacture, and delivery life cycle, using the GAMP-4 life cycle approach to their validation. Rich with case studies and real-life examples, it also supplies the reader with true applications of GAMP 4 to different areas of regulations, such as good laboratory practice, good clinical practice, good manufacturing practice, and good data practice.
Book Specifications
ISBN-13 9780849323249
Language English
Binding Hard Bound
Publisher Informa Healthcare
Publishing Date 2005-08-03
Total Pages 576